antigravity esd double-balloon-assisted underwater with

IntroductionComplex colorectal polyps defined as those greater than 2 cmor those positioned in difficult anatomic locations can be a ma-jor challenge for endoscopic therapy [1–3]. Underwater endo-scopic submucosal dissection (UESD) has recently emerged as apotential technical solution to facilitate complex polyp removal[4]. The major benefits of UESD are gravity-assistance indepen-dence, magnification, hydro-dissection, reduced tissue burnartifact and electrosurgical smoke reduction [4–6]. In addition,tissue traction and counter-traction, cornerstone principles ofeffective dissection, have been confined to limited methods

ranging from clipping/retraction to using dual endoscopes[7–9]. Despite the clear benefits of endoscopic submucosaldissection (ESD) (en-bloc resection and low recurrence rate), itremains a technically challenging procedure with higher per-foration rates compared to endoscopic mucosal resection(EMR) [10]. This difficulty can be particularly amplified whenthe lesion is unamenable to gravity assistance, i. e. located inthe inferior portion of the clock face. Double- and single-bal-loon systems have demonstrated some utility within the endo-lumenal space, particularly in small bowel locomotion and sta-bilization of the scope within the lumen when performing ad-vanced endoscopic procedures [11, 12].

Antigravity ESD – double-balloon-assisted underwater withtraction hybrid technique

Authors

Sam K. Sharma, Takahiro Hiratsuka, Hisashi Hara, Jeffrey W. Milsom

Institution

Minimally Invasive New Technologies, Department of

Surgery, Weill Cornell Medicine, New York Presbyterian

Hospital, New York, New York, United States

submitted 3.7.2017

accepted after revision 5.2.2018

Bibliography

DOI https://doi.org/10.1055/a-0578-8081 |

Endoscopy International Open 2018; 06: E739–E744

© Georg Thieme Verlag KG Stuttgart · New York

ISSN 2364-3722

Corresponding author

Sam K. Sharma, Minimally Invasive New Technologies,

Department of Surgery, Weill Cornell Medicine, New York

Presbyterian Hospital, New York, New York, United States

Fax: 212-746-8750

[email protected]

ABSTRACT

Background and study aims Complex colorectal polyps

or those positioned in difficult anatomic locations are an

endoscopic therapeutic challenge. Underwater endoscopic

submucosal dissection (UESD) is a potential technical solu-

tion to facilitate efficient polyp removal. In addition, endo-

scopic tissue retraction has been confined to limited meth-

ods of varying efficacy and complexity. The aim of this

study was to evaluate the efficiency of a unique UESD tech-

nique for removing complex polyps using double-balloon-

assisted retraction (R).

Materials and methods Using fresh ex-vivo porcine rec-

tum, 4-cm polyps were created using electrosurgery and

positioned at “6 o’clock” within an established ESD model.

Six resections were performed in each group. Underwater

techniques were facilitated using a novel double-balloon

platform (Dilumen, Lumendi, Westport, Connecticut, Unit-

ed States).

Three different polypectomy methods were compared:

1. UESD with retraction (UESD-R), 2. UESD, 3. Traditional

cap-assisted ESD technique.

Results UESD-R had a significantly shorter total procedur-

al time than cap-assisted ESD and UESD alone (24 vs. 58

vs. 56 mins). UESD-R produced a dissection time on aver-

age of 5 minutes, attributed to the retraction provided.

There was also a subjective significant reduction in elec-

trosurgical smoke with the underwater techniques contri-

buting to improved visualization.

Conclusions Here we report the first ex-vivo experience

of a unique double-balloon endoscopic platform optimized

for UESD with tissue traction capability. UESD-R removed

complex lesions in significantly shorter time than conven-

tional means. The combined benefits of UESD and retrac-

tion appeared to be additive when tackling complex polyps

and should be studied further.

Original article

Sharma Sam K et al. Antigravity ESD –… Endoscopy International Open 2018; 06: E739–E744 E739

Using an ex vivo tissue model, we explored a hybrid approachusing UESD facilitated by a unique endoscopic double-balloonsystem that also permits tissue retraction, to decrease technicaldifficulty and increase safety. The Dilumen double-balloon (DB)platform is a US Food and Drug Administration – approved com-mercially available double balloon oversheath device (Dilumen;Lumendi, Westport, Connecticut, United States) mounted ontoadult and pediatric colonoscopes. The device allows inflation oftwo independently controlled balloons, enhancing endoscopicstability and visualization. In addition, the device provides tissuetraction through clipping of tissue to the balloon (▶Fig. 1).

The aim of this study was to evaluate the efficiency of aunique UESD technique for removing complex polyps usingdouble balloon-assisted retraction (R).

Materials and methodsUsing fresh ex-vivo porcine rectum, 4-cm polyps were createdusing electrosurgery and positioned at “6 o’clock” (4-cm polypwith 5-mm margin) within an established ESD model. The posi-tion of the lesion was intentionally placed at 6 o’clock to in-crease the difficulty with negative gravity effect. Two lesionswere placed on each animal specimen in diametrically oppositepositions so as to utilize the animal specimen to its maximum.Six resections were performed in each group.

Three different polypectomy methods (equipment listed be-low) were compared:1. UESD with retraction (UESD-R)2. UESD no retraction3. Traditional cap-assisted ESD technique.

Dilumen use

The Dilumen device was mounted onto a colonoscope (Olym-pus PCF-H180AL; Olympus Corporation, Japan). Upon insertioninto the model and at an appropriate section related to the le-sion, the Aft-Balloon (AB) inflation selector was selected via theinflation handle control knob. The inflation/deflation bulb wasdepressed until the desired pressure was reached (indicated bythe indicator turning green). Upon confirmation of scope sta-bility using slight longitudinal movements on the scope shaft,the Fore-Balloon (FB) was extended beyond the endoscope tipusing the FB slider located on the handle of the device. Uponextension to the desired distance the FB inflation position wasselected and the inflation bulb was again squeezed to inflatethe FB, the degree of which was confirmed using the indicatoras well as visual representation on the endoscopic view. Afterconfirmation of mucosal gripping, the FB was further extendedusing the handle knob to provide mucosal traction.

UESD technique

A circumferential mucosal incision was made at the lesion mar-gin with the Dualknife (see below for equipment used). Follow-ing this, the balloons were deployed behind and in front of thelesion. After the balloons were inflated, a sealed “therapeuticzone” was created and saline solution instilled. The assistantactivated the water injector pump at the same time the opera-tor activated the electrosurgery. Once dissection was com-

pleted with the IT-nano and cap on the endoscope tip, the fluidwas suctioned out and specimen removed.

UESD-R technique

A circumferential mucosal incision was made at the lesion mar-gin with the Dualknife (▶Video1). Following this, the balloonswere deployed behind and in front of the lesion (▶Fig. 1) as de-scribed above. After the balloons were inflated, a sealed “ther-apeutic zone” was created and saline solution instilled. The in-cision leading edge was dissected further using underwater dis-section. The assistant activated the water injector pump at thesame time the operator activated the electrosurgery. Oncecompleted, the fluid was suctioned out and the mucosal edgeclipped to the base of the fore balloon (▶Fig. 2). Using variabletension on the fore balloon, tissue dissection continued untilresection was completed (using the IT-nano) (▶Fig. 3).

Fore-Balloon Aft-Balloon

▶ Fig. 1 Device set-up.

▶ Fig. 2 Mucosal (white arrows) clipping to balloon (yellow arrows).

E740 Sharma Sam K et al. Antigravity ESD –… Endoscopy International Open 2018; 06: E739–E744

Original article

Cap technique

A circumferential mucosal incision was made at the lesion mar-gin with the DualKnife. Dissection progressed by pressing theendoscope cap into the submucosal plane and progressingwith dissection using the IT-nano.

Variables measured

Variables measured were total procedure time (time from firstsubmucosal injection to complete removal of specimen), dis-section time (non-marking electrosurgery activation time),specimen size and perforations. Data were recorded and ana-lyzed using Graphpad Prism software (Graphpad, UKR). Allprocedures were video recorded and resected specimens pho-tographed. Data were quoted as mean+/– standard deviationand statistical comparisons were made using a one-wayANOVA. A P value <0.05 was considered significant.

1. Submucosal injection2. Circumferential mucosal incision3. Extension of the fore balloon

4. Inflation of the fore balloon5. Instilling saline solution6. Underwater submuscosal dissection

7. Suction of solution and deflation the fore balloon8. The mucosal edge clipped to the base of the fore balloon9. Submucosal dissection using the tension on the fore balloon

▶ Fig. 3 Stages of UESD-R procedure.

Video 1 Antigravity ESD procedure.


Equipment

UESD, UESD-R (DiLumen, Lumendi, LLC) or traditional cap-as-sisted ESD method (Olympus cap D-201-12704) were per-formed using a pediatric colonoscope (Olympus PCF-H180AL).Monopolar electrosurgery was performed using ERBE electro-surgical generator with Olympus Dualknife (KD-650U) and ITnano (KD-612U), 80w Cut 40w Coagulation. Submucosal injec-tion was used in all cases (0.04% methylene blue, normal salinesolution) through a Boston Scientific 25G endoscopic needleinjector. Clips – Olympus EZ clip – Long clip.

Operator experience

One experienced endoscopist (SS) performed all procedures ina sequential fashion i. e. cap, UESD, UESD-R and repeat. Theendoscopist had 3 years’ experience using the model.

ResultsUESD-R had a significantly shorter total procedural time thancap-assisted ESD and UESD (▶Table 1 and ▶Fig. 4, CAP 58 vs.UESD 56 vs. UESDR 24 mins). The same trend was seen with dis-section time (CAP 52 vs. UESD 45 vs. UESDR 5 mins). Surpris-ingly, UESDR produced a dissection time on average of 5 min-

utes (▶Video1), attributed to the retraction provided. The ob-servation that the procedural time did not differ significantlyfrom the UESD group and the standard cap technique indicatedthe benefits of traction devices over the underwater approach.Excised specimen size did not vary significantly between the 3groups (Cap 12.8 cm2 vs. UESD 15.9 cm2 vs. UESDR 16.7 cm2).No perforations were observed.

There was a subjective significant electrosurgical smoke re-duction with the UESD and UESD-R technique contributing toimproved visualization (▶Fig. 5). The combination of dissectionand saline solution irrigation in UESD-R provided rapid dissec-tion of the mucosal leading edge through elevation of the in-cised tissue.

DiscussionAlthough double-balloon endoscopic systems have been avail-able for some time, their utility has been largely confined tosmall bowel enteroscopy [13]. However, recent reports haveattempted to utilize single-balloon technology in performinglarge intestine therapeutic procedures through aiding cecalintubation [14].

ESD and EMR remain the most widespread complex thera-peutic procedures performed in the gastrointestinal tract. ESD

CAP (total) CAP (dissection) UESD (total)

**

**

**

UESD (dissection)ESD technique

UESD-R (total) UESD-R (dissection)

* p < 0.01** p < 0.001

Tim

e (m

inut

es)

100

80

60

40

20

0

▶ Fig. 4 Procedural and dissection time for different dissection techniques.

▶ Table 1 Results with UESD versus UESD-R.

ESD technique (n=6/group) Cap UESD UESD-R Significance

Procedural time (mins +/– SD) 58 (+/–21) 56 (+/–10) 25 (+/–7) Cap vs. UESD=0.97UESD vs. UESD-R =0.005Cap vs. UESD-R =0.003

Dissection time (mins +/– SD) 52 (+/–20) 45 (+/–6) 5 (+/–3) Cap vs. UESD=0.57UESD vs. UESD-R =0.0001Cap vs. UESD-R =0.0001

UESD, underwater endoscopic submucosal dissection; UESD-R, underwater endoscopic submucosal dissection with retraction; SD, standard deviation


Original article

can be considered more challenging due to the technical skillsinvolved in the procedure. Factors making this more difficultare size, location, and lack of gravity assistance. Patient posi-tioning can be employed to facilitate gravity assistance, butthis is not always possible.

Another important factor affecting the long proceduretimes and technical difficulty associated with advanced endo-scopic procedures is lack of robust and effective tissue traction.Tissue traction increases tension of tissues to facilitate efficientdissection. Traction not only aids in tissue dissection but alsoimproves submucosal layer visualization by lifting away the mu-cosal flap from the field of view. This increases safety throughanatomical layer and submucosal vessel identification. Tractionis the most promising avenue for reducing endolumenal proce-dure times and complications.

Multiple endolumenal tissue traction methods have been at-tempted with varying degrees of success. Internal traction usesrings or springs that are clipped to one edge of the incised mu-cosa and then clipped to the opposite facing mucosa [15–17].This method provides continuous traction but cannot generallybe repositioned. Suture and hemostatic clip placement uses a3-0 silk suture tied to a hemostatic clip. Once a mucosal flaphas been developed, the clip with the suture attached is de-ployed on the lesion edge. The free end of the suture outsidethe patient is pulled towards the endoscope tip, thereby provid-ing tissue traction towards the operator [18]. Clip-and-snarepulling uses a hemostatic clip and a snare. After circumferentialincision, the endoscope is externally looped into a snare. Thescope and snare are reinserted into the patient. A workingchannel introduced hemostatic clip grasps the incised mucosalflap. The snare is pressed up to the clip. After tightening thesnare to grasp the clip, it is deployed providing traction towardsthe operator [19]. With external forceps, an accessory workingchannel – an external channel placed outside the colonoscope –is used to deliver a second grasping forceps, which grasps the

lesion edge. Traction direction can be either towards or awayfrom the endoscope tip. This method has been reported toincrease the risk of mucosal injury upon insertion [20]. Withthe double-scope method, a smaller-caliber endoscope isinserted alongside the main scope. Using grasping forceps, thesmaller-caliber scope grasps the incised mucosa while the mainscope dissects. Because this method requires two operators, itis not always feasible [21].

There are multiple challenges associated with these meth-ods. Most are technically difficult, require two operators in thecase of the double endoscope method and pull the tissue to-wards the scope tip, which is not ideal in the case of tissue dis-section. The ideal position is traction away from the perspectiveof the operator. In addition, most studies reporting tractionmethods are for gastric lesions.

Electrosurgical tool use is a necessity for complex thera-peutic procedures. However, it can cause significant smokeproduction as well as fat deposition on the endoscope lens,sometimes requiring removal of the endoscope from the pa-tient and cleaning of the lens, thus decreasing efficiency.

Here we report the first ex-vivo experience with a uniquedouble-balloon endoscopic platform optimized for UESD withtissue traction capability. In lesions considered difficult (4 cmand at 6 o’clock), UESD-R removed lesions in significantlyshorter time than conventional means. Our experience alsosubjectively showed a significant decrease in smoke obscuringthe dissection capability of the dissection. Similar experienceshave been quoted in the literature [4–6]. Employing doubleballoon technology to facilitate underwater dissection, to ourknowledge, has never been described before in the literature.

This study has several limitations, including its ex-vivonature. The porcine model, although well established as anESD trainer, has several limitations that limit its accuracy in-cluding lack of contractions, respiration, submucosal fibrosisand bleeding. Six resections in each group is a small number of

▶ Fig. 5 Electrosurgical smoke production non-underwater versus underwater.


procedures, which prevented any learning curve calculations.Smoke production is difficult to measure, however, severalstudies have corroborated our findings and we included visualrepresentation of the endoscopic view to demonstrate this tothe viewer. Our dissection strategy may not be considered opti-mal, i. e. performing a circumferential incision. This point andthe lesion position at 6 o’clock may not fully simulate the realityof ESD procedures currently.

ConclusionIn conclusion, the double-balloon system enabled UESD-R. Thisled to significantly shorter observed procedural and dissectiontimes versus traditional ESD methods. The combined benefitsof UESD and retraction appeared to be additive when tacklingcomplex polyps unamenable to gravity assistance and shouldbe studied further.

Competing interests

Milsom: Clinical advisory board member lumendi.

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Original article

antigravity esd double-balloon-assisted underwater with

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